The Prevent Coronary Artery Disease Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30-50
SponsorIcahn School of Medicine at Mount Sinai
About this trial
Despite increasing evidence that exposure to cardiovascular risk factors (CVRF) at an early age increases the prevalence of subclinical atherosclerosis and is associated with a greater risk of cardiovascular events later in life, there is a lack of randomized trial evidence to support primary prevention strategies in adults aged 30-50 years. The researchers have designed a randomized controlled trial to evaluate whether strict control of CVRF in young adults without known cardiovascular disease, will reduce the progression of total atherosclerosis burden, a surrogate endpoint for symptomatic cardiovascular disease, compared with usual care.
The researchers propose a randomized controlled trial enrolling 1,600 healthy young adults who meet the inclusion criteria and who do not meet any exclusion criteria. Eligible study participants will be randomized, in a 1:1 ratio, to either the intervention group (active treatment strategy) or to the control group (guideline-directed medical therapy). Randomization will be stratified by the presence or absence of atherosclerotic plaque in vascular ultrasound.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects between 30 to 50 years of age.
No prior history of coronary artery disease, cerebrovascular disease or peripheral artery disease.
Serum LDL-C > 1.8 mmol/l (70 mg/dl).
Presence of subclinical atherosclerosis as assessed by 3DVUS or by the presence of coronary artery calcium (defined as coronary artery calcium score ≥25), independent of risk calculators; and/or high lifetime risk (≥30%) using the ASCVD calculator; and/or intermediate 10-year risk (≥7.5%) using the ASCVD calculator in the presence of 2 risk enhancers.
Disqualifiers
An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of highly effective contraception (failure rate less than 1% per year) (e.g. combined oral contraceptives, barrier methods, approved contraceptive implant, long- term injectable contraception, or intrauterine device) for the entire duration of the study.
Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 5 years.
History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three years prior to randomization
Trial design
Design model
Parallel
Treatments tested in this trial
Inclisiran
DrugSubjects will be administered a single subcutaneous injection of 284 mg inclisiran for injection at predefined time points.
Treatment groups
1,600 Participants
are divided into 2 treatment groupsGroup A: InclisiranExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in atherosclerotic plaque burden from baseline
Change in atherosclerotic plaque burden at 2.5 years and the last year of follow up from baseline as measured by the 3D vascular ultrasound. Atherosclerotic plaque burden is amount of plaque in the arteries.
Time frame
Baseline, 2.5 years and 5 years after randomizationSecondary outcomes
1
Change in Number of participants with Cardiovascular Disease (CVD)
Change in Number of participants with Cardiovascular Disease (CVD) at 5 years as compared to baseline. CVD includes myocardial infarction, stroke, revascularization), cardiovascular death and all cause death.
Time frame
Baseline and 5 years after randomizationSponsors and contacts
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Source ClinicalTrials.gov